FDA Draft Action Plan for Acrylamide in Food

Summary

FDA has developed a draft action plan for acrylamide in food. The draft action plan outlines FDA's goals and planned actions on the issue of acrylamide in food and includes a timeline of planned meetings. It also discusses FDA's intentions to work with other federal agencies and to participate in international efforts. This action plan will guide FDA's activities on the issue of acrylamide over the next several years. FDA will make the plan available on the CFSAN website. FDA will also present the plan for public and scientific comment at a public meeting on September 30, 2002, with follow-up discussion at a Food Advisory Committee subcommittee meeting in December 2002, and a full Food Advisory Committee meeting in February or March 2003. The draft action plan is a working document, and FDA will revise the plan, as needed, based on public comment from these meetings and on knowledge gained from research developments.

Background

On April 24, 2002, researchers at the Swedish National Food Administration and Stockholm University reported finding the chemical acrylamide in a variety of fried and oven-baked foods. The initial Swedish research indicates that acrylamide formation is particularly associated with traditional high temperature cooking processes for certain carbohydrate-rich foods. Since the Swedish report, similar findings have been reported by Norway, the United Kingdom, and Switzerland. Preliminary analysis by the FDA suggests that U.S. results will be in basic agreement with these findings. The discovery of acrylamide in foods is a concern because acrylamide is a potential human carcinogen and genotoxicant.

Mechanism

Acrylamide appears to form as a byproduct of high-temperature cooking processes (greater than 120°C or 248°F). It does not appear to be present in food before cooking. Research to date suggests that acrylamide formation is particularly likely in carbohydrate-rich foods. However, tests on carbohydrate-rich foods cooked at lower temperatures (e.g., by boiling) have shown much lower acrylamide levels. At this time, not enough is known about acrylamide formation to identify safe modifications to food processing techniques that will clearly prevent or reduce formation. Identifying mechanisms of formation will ultimately be an important step in identifying ways to reduce or prevent acrylamide formation during cooking.

Toxicology

There are uncertainties about the impact of acrylamide on public health. People have been eating some of the foods now reported to contain acrylamide for many years. To better assess the risk of acrylamide, more information is needed regarding which foods acrylamide is formed in, levels of acrylamide in foods, dietary exposure to acrylamide, the bioavailability of acrylamide in food, the potential of acrylamide to cause cancer when consumed in food, acrylamide's potential to cause germ cell mutations, and biomarkers of acrylamide exposure.

Acrylamide causes cancer in laboratory animals. As a result, acrylamide is considered a potential human carcinogen. However, it is not clear whether acrylamide causes cancer in humans. Scientists have conducted epidemiological studies of people exposed to acrylamide in the workplace. The studies did not show increased cancer risk with acrylamide exposure. However, these studies do not rule out the possibility that acrylamide in food can cause cancer, both because of the limited number of people in the studies and because the route of exposure for the workers was not through food.

WHO/FAO Recommendations

In June 2002, the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) convened an expert consultation on acrylamide. The consultation, which was attended by three FDA experts, concluded that the presence of acrylamide in food is a major concern, and recommended more research on mechanisms of formation and toxicity. Both the WHO/FAO consultation and the FDA have recommended that people continue to eat a balanced diet rich in fruits and vegetables. The WHO/FAO consultation advised that food should not be cooked excessively, i.e., for too long or at too high a temperature, but also advised that it is important to cook all food thoroughly--particularly meat and meat products--to destroy foodborne pathogens (bacteria, viruses, etc.) that might be present.

FDA's Goals and Actions on the Issue of Acrylamide in Foods

Addressing the issue of acrylamide in foods will require research and activity on multiple fronts. Planned and current actions by the FDA include assessing the dietary exposure of U.S. consumers to acrylamide, gathering new information about the toxicology of acrylamide, and participating in the development of techniques for reducing acrylamide formation. As more data become available on acrylamide, FDA will continue to develop public health messages and regulatory options.

Major goals

Assess the dietary exposure of U.S. consumers to acrylamide by measuring acrylamide levels in various foods.

Assess the potential risks associated with acrylamide in foods by extensive evaluation of the available information and by expanding research into acrylamide toxicology.

With partners, identify mechanisms responsible for the formation of acrylamide in foods and identify means to reduce acrylamide exposure.

Inform and educate consumers and processors about the potential risks throughout the assessment process and as knowledge is gained.

Develop and foster public/private partnerships to gather scientific and technological information and data for assessing the human risk.

Actions

Development of draft action plan

FDA has developed this draft action plan to outline its actions and goals on the acrylamide issue. FDA is presenting this draft action plan for input and comments from the public, academia, industry, and scientific experts.

Testing foods

FDA is currently testing a limited number of locally collected foods in its laboratories at the Center for Food Safety and Applied Nutrition (CFSAN). In FY03, FDA also plans to test a larger number of samples collected nationwide by FDA's Office of Regulatory Affairs for analysis by CFSAN and possibly other government and non-government laboratories. The local and national samples will be used to estimate variation within and across key food types as part of processing evaluations and to determine the incidence of formation across the food supply. For FY03, FDA also plans to collect and analyze Total Diet Study (TDS) market basket samples to identify exposures from specific U.S. foods. Further testing may occur in FY03 based on the findings of the initial survey and formation research.

Toxicology

Development of new data on toxicology will provide more information about acrylamide and facilitate risk management choices. FDA is initiating and participating in research on a variety of toxicology related issues.

FDA's National Center for Toxicological Research (NCTR) is proposing to conduct the following short-term studies:

Compare and contrast the bioavailability of acrylamide in both mice and rats when dosed via drinking water and in the diet. These studies should clarify how acrylamide is absorbed in a food matrix and shed light on the significance of previous toxicology assays in which rats were administered acrylamide in drinking water.

Identify acrylamide-related DNA and protein adducts and study the formation of these adducts in mice and rats exposed to acrylamide. Acrylamide-related adducts are reaction products between acrylamide and its metabolites and DNA and proteins.

Correlate adduct data from rats with adduct measurements in humans whose only known exposure to acrylamide is through background levels in food or through smoking.

FDA NCTR plans to nominate acrylamide and its reactive metabolite glycidamide to the National Toxicology Program as FDA's high priority chemical selections for fiscal year 2003. FDA will request that subchronic toxicity studies, chronic carcinogenicity studies, and supportive mechanistic studies be conducted for both acrylamide and glycidamide. NCTR would conduct these studies through an interagency agreement between FDA and National Institute of Health's (NIH) National Institute for Environmental Health Sciences (NIEHS). FDA will therefore participate in all experimental protocol designs to assure regulatory needs are met.

FDA will work with the Centers for Disease Control (CDC) to evaluate the use of acrylamide-related protein adducts for monitoring acrylamide exposures in humans. FDA and CDC will discuss the possibility of including monitoring acrylamide adducts in the National Health and Nutrition Examination Survey (NHANES), a national health survey that collects biological samples and health data from people throughout the U.S.

Research and outreach on formation

FDA will investigate mechanisms of acrylamide formation and processes for reducing formation of acrylamide through the National Center for Food Safety and Technology (NCFST) in Illinois, a consortium between FDA, the Illinois Institute of Technology, and food-related industries.

Through its collaboration with industry, FDA will encourage industry to adopt processes that are successful at reducing acrylamide.

FDA will develop educational material to inform consumers about recommended changes in cooking methods to reduce acrylamide, taking into account the need to balance other potential risk factors for consumers, such as the risk of microbial contamination with reductions in cooking time.

FDA will continue to interact with academia and industry to encourage research on mechanisms of acrylamide formation and effects of process changes on acrylamide levels. FDA is fostering such interactions through NCFST and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a consortium between FDA and the University of Maryland.

Methodologies

FDA will continue to update and validate its current liquid chromatography/tandem mass spectrometry (LC/MS/MS) methodology as needed. FDA developed its own LC/MS/MS methodology for testing for acrylamide in foods and posted this methodology on the CFSAN website on June 20, 2002. The methodology was updated on July 23, 2002.

Researchers at CFSAN will evaluate screening methodologies for more rapid and less expensive detection of acrylamide in the food supply.

Meetings and collaborative projects

FDA is planning to convene or participate in multiple meetings with the goals of (a) gathering public and expert input on acrylamide in food and (b) fostering coordination of research efforts on acrylamide.

CFSAN is conducting an interagency roundtable of federal public health agencies involved in acrylamide research on September 24, 2002. Participants in the roundtable include Department of Health and Human Services (FDA, the National Institute of Environmental Health Sciences, and the National Institute of Occupational Safety and Health and the National Center for Environmental Health of CDC), the United States Department of Agriculture (Food Safety Inspection Service, Agricultural Research Service), and the Environmental Protection Agency (EPA). Topics include the results of the WHO consultation, plans for acrylamide toxicology studies at each agency, EPA's reevaluation of its dose-response evaluation for acrylamide, the potential use of biomarkers to monitor acrylamide exposure, epidemiological studies, occupational exposures, and heritable mutagen assays. FDA will continue to chair this interagency group to review ongoing developments relating to acrylamide.

FDA is convening a Public Meeting, "Assessing Acrylamide in the U.S. Food Supply," on September 30, 2002, to update the public on FDA's activities related to acrylamide in food, to present FDA's draft action plan for acrylamide, and to obtain comments on the plan.

FDA will hold a meeting of the Subcommittee on Contaminants and Natural Toxicants of the FDA Food Advisory Committee in early December 2002. At the meeting, FDA will present its draft action plan for acrylamide, revised to reflect comment from the September 30, 2002, public meeting, and will also present preliminary data on acrylamide levels in foods. FDA will seek input on the draft action plan, on research and analysis needs, and on exposure and toxicology issues.

FDA will hold a meeting of the full FDA Food Advisory Committee in late February or early March 2003. FDA will present its revised draft action plan, updated to reflect input from the Subcommittee on Contaminants and Natural Toxicants, as well as preliminary data on acrylamide levels in foods and more specific information on ongoing or planned research. FDA will seek input on the draft action plan, on research and analysis needs, and on exposure and toxicology issues.

The Codex Committee on Food Additives and Contaminants meets March 17-21, 2003. The U.S. delegation will work with other delegations to ensure that acrylamide is assessed.

If invited, FDA scientists will participate in an assessment of acrylamide by the WHO/FAO Joint Expert Committee on Food Additives and Contaminants (JECFA), tentatively planned for winter or spring 2004.

JIFSAN will serve as a clearinghouse for continued international coordination and data sharing on acrylamide.

Consumer messages

FDA will develop and revise consumer messages about dietary choices and cooking methods, as additional knowledge is gained about acrylamide in food.

Regulatory options

FDA will develop and revise regulatory options as additional knowledge is gained on acrylamide in food. Many of the items in the draft action plan are geared toward achieving that end.

The following table highlights the timeline of activities on acrylamide.